Monoclonal Antibodies (mAbs)

Proven Lyophilization of RTU Nested Vials

Trend and insights
The biologics market is growing enormously. Due to the low stability of biologics, 24% of biologic drugs newly approved by the FDA between 2017 and 2021 are lyophilized.

Challenge
EZ-fill^® nested vials are in a suspension frame “nest”, contrary to conventional loading where the vials are in direct contact with the freeze-dryer shelf. The suspended configuration avoids glass-to-glass contact during the filling phase and reduces mechanical stress which could lead to vial breakage but it may raise doubts about the heat transfer mechanism from the shelf to the vials.

Solution
Stevanato Group, in collaboration with the Politecnico di Torino University (POLITO), has conducted a series of tests on freeze-drying pharmaceuticals in nested vials demonstrating that EZ-fill^® Vials are high-value solutions for lyo products.

The overall study results, performed on a 3ml ISO vial, not only confirmed the usability of nested vials for lyophilization but, above all, demonstrated their potential as a high-value solution for freeze-dried pharmaceutical products.

Comparison of vials in bulk and EZ-fill^® configuration throughout a lyophilization process

Objective
verify thermal properties of the nest during and after freeze-drying process, focusing on the impact on time of freeze-drying cycle and on intra-batch variability

Results

EZ-Fill^® Nest & Tub configuration, in comparison to Bulk configuration:

• Simplify lyophilization industrial cycle scale-up with no impact on cycle time
• Reduce intra-batch variability, improving the overall quality of the lyophilized cake

Conclusions

• The temperature difference between the vials and the NEST is very limited = limited impediment of the nest to the heat transfer.
• Chamber pressure has less impact on the Kv (heat transfer coefficient) in vials in NEST, compared to the SHELF configuration

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